Thursday, April 28, 2011

Despite the fact that people are dying from taking Chantix due to its nearly immediate mental health effects, a new article on the short-term effectiveness of Chantix fails to even make mention of the existence of these severe side effects.

The article (Hajek P, McRobbie HJ, Myers KE, Stapleton J, Dhanji A-R. Use of Varenicline for 4 Weeks Before Quitting Smoking: Decrease in Ad Lib Smoking and Increase in Smoking Cessation Rates. Archives of Internal Medicine 2011; 171(8):770-777) assesses the effectiveness and side effects of pre-cessation use of Chantix combined with post-cessation use of the drug, and follows patients for one month following their quit attempt.

It reports on relatively minor side effects such as nausea. However, it fails to report, mention, or acknowledge the severe side effects that have been observed with Chantix, including major psychological symptoms, depression, wide mood swings, violent and suicidal ideation, and attempted and completed suicide. The study even assessed depressive symptoms in patients, but does not report these results.

The glaring lack of even a mention of the severe side effects of Chantix is a surprising act of omission.

The Rest of the Story

However, that surprise disappears when one gets to the bottom of the article, in the fine print, where it discloses that the study was funded by Pfizer (the maker of Chantix) and that several of the authors have financial conflicts of interests with pharmaceutical companies that make smoking cessation drugs.

Regarding the research funding, the article discloses: "This study was supported by an investigator-initiated grant from Pfizer (Dr Hajek), who also supplied the study medication."

Regarding the conflicts of interest, the article discloses: "Drs Hajek and McRobbie have received research funding from and provided consultancy to manufacturers of smoking cessation medications. Mr Stapleton was formally an adviser to manufacturers of smoking cessation medications, for which he received remuneration and hospitality."

It therefore comes as no surprise, actually, to find that the article makes no mention of the fact that hundreds of patients have experienced severe and often violent side effects, that nearly 100 have committed suicide, and that several bodies which have examined these case histories appear to have concluded that these adverse effects were indeed caused by the medication.

While I find it quite sad that so many people have needlessly lost their lives due to Chantix, I find it disturbing and unacceptable that bias caused by financial conflicts of interest has most likely contributed to these deaths.

Wednesday, April 27, 2011

The FDA's Tobacco Products Scientific Advisory Committee (TPSAC) report and "recommendations" on menthol cigarettes is already being used to block a menthol ban, demonstrating that the TPSAC didn't know what it was talking about when it argued that its report clearly recommended that menthol cigarettes be banned.

Last week, Senator Richard Blumenthal wrote to the FDA seeking a ban on menthol cigarettes. In response, however, the Center for Regulatory Effectiveness (CRE) - citing TPSAC's own report - noted that the FDA cannot ban menthol cigarettes until a study is carried out on the issue of contraband cigarettes that could arise if menthol cigarettes are banned.

According to CRE's press release: "Senator Blumenthal states that his recommendation to ban menthol cigarettes is based on the report of the FDA Tobacco Product Scientific Advisory Committee. Unfortunately he must have not read the report in its entirety. The TPSAC made it clear that no action can be taken on a ban until the issue of contraband has been addressed."

The Rest of the Story

The Center for Regulatory Effectiveness is absolutely correct. The TPSAC's report, rather than recommend a ban on menthol, actually cautioned against such a ban, requesting that the FDA conduct a study of the contraband issue before embracing any particular policy regarding menthol.

Nevertheless, the chair of the TPSAC panel told the media that the Committee did in fact make a clear recommendation. This flies in the face of the clear language of the TPSAC's report.

The rest of the story is that rather than offer a recommendation, TPSAC punted the issue back to the FDA and shirked its responsibility. The Committee was statutorily charged with making a recommendation to the FDA about whether to ban menthol cigarettes, taking into account the issue of potential contraband. The Committee failed to carry out this charge.

At the end of the day, all the TPSAC menthol report actually does is put an even larger hurdle in the path of a potential menthol cigarette ban. It delays any such policy by years, requiring the FDA [unless the Agency ignores the report] to conduct a contraband study before even proposing a policy. Most importantly, it gives the Agency an out whereby it can respond to politicians like Blumenthal by simply noting that its hands are tied: it cannot act because we don't know about the potential effects of a contraband menthol cigarette market.

Lastly, the TSPAC report not only delays a potential menthol ban by years, but in doing so, takes the wind out of the sails of advocates who have been pushing for such a ban. The issue is going to be lost among the many other things that the FDA considers in the upcoming years, and the chance that the public health community had to advocate for such a policy has been squandered.

By the way, this is exactly the way the process is supposed to work. By exempting menthol from the Tobacco Act's flavoring ban and instead, appointing a committee to "study" the problem, Congress (and sadly, the Campaign for Tobacco-Free Kids) got exactly what they intended: the exemption of menthol cigarettes so that there would be no substantial reduction in cigarette profits, thus retaining Philip Morris' support for the legislation and keeping the negotiated deal in tact.

This was made easier because it was the health of the African American community that was offered to Philip Morris as a bargaining chip. It's a lot easier to trade away the rights and interests of marginalized communities - especially communities of color - with less political power. If the interests of white males were at stakes, things would have looked very different.

Sadly, as Bob Robinson was the first to point out and constantly reminds us, it is not the tobacco companies but the Campaign for Tobacco-Free Kids which was the first to jump forward with the argument that menthol cigarettes need to remain on the market because of the potential of a contraband market if they are banned. With friends like the Campaign for Tobacco-Free Kids, Lorillard did not even need to do its own advocacy work to protect its menthol cigarette sales. The Campaign did the dirty work for them.

Tuesday, April 26, 2011

The Food and Drug Administration (FDA) announced yesterday that it will accept the ruling of the D.C. Court of Appeals and regulate electronic cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act, rather than as drug-device combinations under the Food, Drug, and Cosmetic Act, as long as the manufacturers do not make therapeutic claims.

The FDA plans to issue specific regulations and guidances regarding electronic cigarettes that will clarify exactly how the Agency plans to deal with these products under the Tobacco Act. One major potential guidance is how the Agency will interpret the term "therapeutic claims" with regards to electronic cigarettes.

The FDA wrote: "The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes. The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera."

An important detail that the FDA spelled out yesterday was that the Tobacco Act grandfathers in only products that were on the market as of February 15, 2007 or which are substantially equivalent to such products: "'Tobacco products' marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent."

The Rest of the Story

The implications of the FDA's action depend largely on how the Agency chooses to implement the regulation of electronic cigarettes. Therefore, many of the implications of the action are unclear. Below, I have tried to articulate what we definitely know and what we don't know at this point.

What We Know

1. Most importantly, electronic cigarettes will be regulated as tobacco products under the Tobacco Act. The most critical implication of this fact is that these products will not be completely removed from the market. Electronic cigarettes will remain available, which is of tremendous public health significance as many vapers are using these products to stay off of tobacco cigarettes.

2. Electronic cigarette companies will remain free from regulation under the Food, Drug, and Cosmetic Act as long as they refrain from making therapeutic claims. Electronic cigarette companies can safely market electronic cigarettes as smoking alternatives without running afoul of the FDA's guidance.

3. Electronic cigarette companies will need to refrain from making therapeutic claims, unless they put their products through the drug approval process. While the FDA has yet to issue guidance as to what a "therapeutic claim" means with regard to electronic cigarettes, it is clear that electronic cigarette companies cannot claim that these products are intended to treat any disease, such as smoking addiction. No claim can be made that the product will treat nicotine withdrawal symptoms. What is not clear is whether a claim that the product can help a person quit smoking would be considered a therapeutic claim (see below).

4. Electronic cigarette companies will not be able to claim that these products are safer than smoking. While this is ridiculous because there is no question that these products are safer than tobacco cigarettes, it is - unfortunately - the law. This is in fact one of the major reasons why I opposed the Family Smoking Prevention and Tobacco Control Act in the first place. I have written extensively about why the modified risk provisions of the Tobacco Act are antithetical to public health goals. Nevertheless, the law is the law and electronic cigarette companies will not be able to tell the public of the chief benefit of these products: that they are safer than regular cigarettes. Of course, that doesn't stop others - outside of the industry (such as myself) - from informing the public about the relative safety of electronic cigarettes compared to regular ones. It also doesn't stop electronic cigarette companies from submitting an application to the FDA to have their products approved as reduced risk products. But it is unclear what evidence would be required to achieve such a designation.

5. Some brands of electronic cigarettes could potentially be pulled off the market. It all depends on how the FDA interprets the phrase "substantially similar." Electronic cigarettes that were on the market as of February 15, 2007 are fine. But brands introduced subsequent to that date could be determined to be "new" products and would therefore need approval by the FDA. It is unclear whether companies could successfully obtain such approval. On the other hand, all electronic cigarettes are quite similar, and it is also possible that companies could successfully argue that their brands are "substantially similar" to brands that were on the market as of February 15, 2007.

6. All electronic cigarette companies will have to comply with certain blanket requirements, such as registration of their products, disclosure of ingredients, and good manufacturing practices. Companies may also be subject to user fees to help defray the cost of regulation.

What We Don't Know

1. How will the FDA interpret "substantially equivalent" regarding electronic cigarettes? Since all electronic cigarettes are basically very similar, it could be that they are all substantially equivalent to products on the market as of February 15, 2007, and that all brands can therefore remain on the market. But it is unclear whether that is the approach that the FDA will take.

2. How will the FDA interpret "therapeutic claims" regarding electronic cigarettes? The key question is whether stating that these products can help people quit smoking represents a therapeutic claim. Elsewhere, I have argued that such a claim is not a therapeutic claim because smoking is not a disease, but a behavior." Unless companies state that the product is intended to prevent nicotine withdrawal symptoms, then they are not making a therapeutic claim. But it is not at all clear whether the FDA will accept this interpretation.

3. Would the FDA approve an electronic cigarette brand not on the market as of February 15, 2007 as a new tobacco product? If the FDA does not allow brands that were not on the market as of February 15, 2007 to be grandfathered in as "substantially equivalent" products, will the Agency approve them as new products? For this to happen, the company would have to demonstrate that these products would benefit the public's health. I think there is sufficient evidence to make such a claim, but will the FDA?

4. Will the FDA approve reduced risk claims for electronic cigarettes? It is clear that electronic cigarette companies cannot continue to make reduced risk claims because their products would then violate the Modified Risk provisions of the Tobacco Act. However, the question is whether they could successfully apply for modified risk designation. I believe there is sufficient evidence to support such a designation, but will the FDA?

Conclusions

All in all, this is a good thing for the public's health. Regulating electronic cigarettes under the Food, Drug, and Cosmetic Act would essentially remove these products from the market, causing tremendous harm to current and potential future users of these products. Regulating electronic cigarettes under the Tobacco Act is appropriate and ensures that they will remain available to smokers who want to quit and to ex-smokers who have already quit using these products

Just how beneficial this is for the public's health will depend on how the FDA answers the four questions above. How stringent or lenient will the Agency be in interpreting the meaning of "substantially equivalent" and "therapeutic claim" with regard to electronic cigarettes under the Tobacco Act and how much evidence will the Agency require for companies to successfully obtain a designation of their products as being "reduced risk" products?

I will continue to follow this issue and report on any regulations or guidances that the FDA issues.

Monday, April 25, 2011

According to an article in yesterday's Boston Globe, pharmacy tobacco sales bans are spreading across Massachusetts, with nine cities and towns have enacted such policies in the past three years. The justification for these policies, as expressed by one of the town's tobacco control coordinators, is that the laws are necessary to prevent the hypocrisy of stores selling healthful products and cigarettes at the same time.

According to the article: "The pace of Massachusetts cities and towns banning tobacco sales at pharmacies appears to be accelerating: Of nine such bans that have taken effect since early 2009, four began this year, and more are under consideration. South of Boston, Sharon defeated a proposed ban April 11, but the Wareham Board of Health may opt for one, according to Bob Collett, director the Cape Cod Regional Tobacco Control Program. Collett made a presentation to the Wareham board recently. 'I’m confident that it will happen there,' he said. 'They do understand the obvious hypocrisy of selling tobacco in a health care setting such as a pharmacy, and they have supported tobacco control efforts in the past.'"

The Rest of the Story

I just don't see how government intervention is justified for the purpose of preventing hypocrisy. If that were the case, it would justify a slew of laws to regulate the behavior of tobacco control groups. For the Campaign for Tobacco-Free Kids alone, there would be about 25 laws on the books.

Yes, it is hypocritical for pharmacies that market themselves as being part of the health care establishment to also sell cigarettes. But it is far more hypocritical for policy makers to send the message that selling cigarettes in pharmacies is bad, while selling them in gas stations and convenience stores is just fine.

Preventing hypocrisy is not a legitimate justification for government intervention into private businesses. I find it highly hypocritical for corporations like Coca-Cola to contribute money to organizations like the American Dietetic Association. That is highly hypocritical, but there is no justification for a government law to prevent such contributions. It is hypocritical for Boston University to host Charlie Sheen for his side-show, but enacting a law to tell the University it can't do that is not warranted. It seems hypocritical for Burger King to sell Whoppers alongside fresh salads, but it doesn't justify a government law to regulate the foods that Burger King can and cannot sell.

Government intervention is justified to prevent the public from health hazards. But the sale of tobacco in pharmacies is not a health hazard. The health hazard is the sale of tobacco, period. In fact, pharmacy sales bans define the problem in the wrong way. They frame the problem as the sale of tobacco in certain types of stores. That's not the problem. The problem is that the products, wherever they are sold, are toxic and addictive.

In the long run, I believe that the focus on pharmacy cigarette sales ban is harming, more than helping the tobacco control cause. Why? Because:

1. These policies do nothing to protect the public's health. They will not reduce the sale of tobacco to minors, because kids will simply buy their cigarettes elsewhere. In fact, most kids don't buy their cigarettes in pharmacies to begin with.

2. These policies frame the issue in exactly the wrong way. They send the message that the sale of cigarettes is perfectly fine, as long as you don't also sell pharmaceutical products. They take the focus off the actual issue at hand, which is that cigarettes are a deadly product, no matter where they are sold.

Friday, April 22, 2011

According to a press release issued by the World Medical Association (WMA), the WMA wants to ban candy and electronic cigarettes, while keeping the real ones.

Also, according to the press release, the American Medical Association claimed that the tobacco industry is aggressively marketing electronic cigarettes.

The press release states: "The World Medical Association will step up its fight against smoking with proposals to ban the production, distribution and sale of candy products that depict or resemble tobacco products. At their three-day Council meeting in Sydney, Australia, (April 7-9) WMA delegates agreed to recommend to their annual Assembly in October plans to strengthen the organisation's anti tobacco policy to combat moves by the tobacco industry to make their products more appealing to young people. Delegates argued that the WMA should extend its policy to include restrictions on smokeless tobacco and tobacco-derived products, including prohibiting all government subsidies for tobacco-derived products. Dr. Ardis Hoven, chair of the Board of the American Medical Association, said the tobacco industry was now involved in aggressively promoting new forms of cigarettes, such as smokeless tobacco and electronic cigarettes in shops and on the internet to attract and appeal to young people, and the WMA needed to respond strongly."

The Rest of the Story

The Medical Association is telling a blatant lie. Tobacco companies have nothing to do with electronic cigarettes. They neither produce nor market these products.

The rest of the story, then, is that the Medical Association is lying. The problem is, it's not clear exactly which Medical Association is lying.

Either the American Medical Association is lying, or the World Medical Association is lying.

The Western Medical Association claims that the American Medical Association chair told the audience that tobacco companies are aggressively marketing electronic cigarettes. So there are two possibilities:

1. The American Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did actually make this claim.

2. The Western Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did not actually make this claim.

Either way, a physician's organization is lying to the public in order to cast electronic cigarettes in a negative light, and thus encourage smokers to stick with regular cigarettes and ex-smokers who have quit by virtue of e-cigs to return to tobacco cigarettes.

Moreover, it appears that both the World Medical Association and the American Medical Association are trying to eliminate the safer alternatives to cigarette smoking, while protecting existing cigarettes from any serious competition and ensuring that the hundreds of thousands of people who are using electronic cigarettes to help quit smoking will be forced to return to their Marlboros, Camels, Newports, Kools, and Salems.

Why are these physician organizations acting to protect the profits of cigarette companies at the expense of the public's health?

And why are they lying to the public in order to achieve that result?

While blatantly lying to the public would be bad enough, lying in a way that is going to encourage people to use a far more harmful product than a safer one is particularly egregious.

Thursday, April 21, 2011

By Partnering With These Corporations, Health Groups Are Actually Working Against the Public's Health

The American Academy of Pediatrics is publicly stating that the Coca-Cola Company is committed "to better the health of children worldwide."

The American Dietetic Association publicly states that the Coca-Cola Company shares its position and policies.

Let's now examine each of these two statements.

The Rest of the Story

1. The American Academy of Pediatrics

Let's examine what it means when the American Academy of Pediatrics states that Coca-Cola is a leader in the movement to improve the health of children worldwide.

What it means is that to improve the health of children worldwide, you can do the following things:

oppose bills in almost every state to restrict the sale of soda and junk food in schools;

oppose bills in almost every state to set school nutrition standards;

send lobbyists to almost every state to defeat or weaken legislation to improve child nutrition; and

deny the scientific evidence that soda contributes to obesity.

In her book, "Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back," Michele Simon examines Coca-Cola's record with respect to supporting public health measures, many of which were supported by the American Academy of Pediatrics. What Simon finds is alarming. Coca-Cola has actively opposed almost every public health measure to improve the nutrition of children, both through its own directly lobbying and through its support of lobbying groups, such as the Grocery Manufacturer's Association (GMA).

Simon writes (page 223): "The GMA is on record as opposing virtually every state bill across the nation that would restrict the sale of junk food or soda in schools. A search for the word "schools" on the GMA Web site resulted in no fewer than 126 hits, most of which are either submitted testimony or a letter filed in opposition to a school-related nutrition policy. Here are just a few examples of document titles: GMA Letter in Opposition of Texas Food and Beverage Restrictions, GMA Letter in Opposition to Oregon School Restrictions Bill, GMA Requests Veto of Kentucky School Restrictions Bill, and GMA Letter in Opposition to California School Nutrition Bill."

Simon continues (page 222-224): "GMA does more than just write letters; the group also has resources to send lobbyists to every state capital in the nation to defeat or weaken legislation. This high-powered lobbying campaign is quite effective. For example, in 2004, GMA helped defeat a California bill that would have set nutrition standards on school food. At every step along the way, the GMA and its member companies have beat nutrition advocates back because they have more lobbying resources, not to mention money to offer politicians in the form of campaign contributions."

Simon concludes (page 224) that "the soda industry is well represented by high-powered lobbyists and regional bottling associations. When it comes to school nutrition, the one company that emerges as the worst corporate actor is Coca-Cola. While other companies also lobby, Coca-Cola puts up the biggest fight and in the nastiest ways. The general rule of thumb that companies like to leave the dirty work to trade groups does not seem to apply to Coke's lobbyists."

Simon's book also reveals that the soft drink industry lobbies against public health legislation deceptively, without even disclosing their affiliation, and that soft drink lobbyists often refute scientific data which clearly show an association between soda consumption and obesity. She writes (page 225): "The soda industry also sent paid consultants to testify at hearings on Philadelphia's districtwide policy without revealing their affiliation. These experts presented industry-sponsored data to show that soda does not cause obesity."

Perhaps most troubling, Simon reveals that Coca-Cola has contributed money which went towards personal attacks against nutrition advocates. Some attacks were horrific, even going to the point of making homophobic statements (page 226).

Why is the American Academy of Pediatrics arguing that the company which is doing all of these things to oppose the protection of the public's health is committed "to better the health of children worldwide"?Why would the American Academy of Pediatrics choose to partner with this company?

Moreover, by touting Coca-Cola as a leader in the effort to improve children's health, I would argue that the American Academy of Pediatrics is not only compromising its integrity, but it is actually working against the public health, because it is undermining efforts to promote policies to improve school nutrition and improve the health of children and adolescents.

The answer, unfortunately, is money. The American Academy of Pediatrics is now bought and paid for by Coca-Cola. Money speaks, and if you pay enough of it, you can even buy off the nation's pediatricians.

2. The American Dietetic Association

Let's examine what it means when the American Dietetic Association states that Coca-Cola shares its positions and policies.

What it means is that the ADA's position and policies must (by logical reasoning) be the following:

oppose bills in almost every state to restrict the sale of soda and junk food in schools;

oppose bills in almost every state to set school nutrition standards;

send lobbyists to almost every state to defeat or weaken legislation to improve child nutrition; and

deny the scientific evidence that soda contributes to obesity.

Why is the American Dietetic Association arguing that the company which is doing all of these things to oppose the protection of the public's health is aligned with the ADA in its policies and positions? Why would the American Dietetic Association choose to partner with this company?

Moreover, by touting Coca-Cola as a leader in the effort to improve children's health, I would argue that the American Dietetic Association is not only compromising its integrity, but it is actually working against the public health, because it is undermining efforts to promote policies to improve school nutrition and improve the health of children and adolescents.

The answer, unfortunately, is money. The American Dietetic Association is now bought and paid for by Coca-Cola. Money speaks, and if you pay enough of it, you can even buy off the nation's nutritionists.

The rest of the story is that the American Academy of Pediatrics and American Dietetic Association (along with the American Academy of Family Physicians and American Cancer Society) should have new slogans to accurate reflect their actions and priorities. I suggest:

The American Academy of Pediatrics: Bought and Paid for by the Coca-Cola Company

The American Dietetic Association: The Chicago Branch of the Coca-Cola Corporation

Wednesday, April 20, 2011

The health groups which supported the Family Smoking Prevention and Tobacco Control Act boasted that one of the great public health benefits of the legislation was that it would save lives by eliminating low yield cigarette descriptors such as "low-tar," "light," and "mild." Smokers would no longer be deceived into thinking that these low-yield cigarettes were safer than others.

The Campaign for Tobacco-Free Kids told the public that the ban on low yield descriptors was "one of the most significant provisions of the law." It asserted that this provision would "prevent tobacco industry deception about tar [and] nicotine levels."

The Rest of the Story

As I predicted years ago, the ban on low yield descriptors has now been shown to have no effect because cigarette companies simply substituted packaging colors to indicate what previously were the low-yield brands. For example, Marlboro Lights are now Marlboro Gold. Moreover, the research shows that smokers understand that these colors represent the low-yield brands and that they still believe that these brands convey lower health risks.

According to a press release summarizing the study findings: "Despite current prohibitions on the words 'light' and 'mild', smokers in Western countries continue falsely to believe that some cigarette brands may be less harmful than others. ... A study published today in the journal Addiction polled over 8000 smokers from Australia, Canada, the United Kingdom and the USA. Approximately one-fifth of those smokers incorrectly believed that "some cigarette brands could be less harmful than others." False beliefs were highest among US smokers. Current research shows that smokers base their perceptions of risk on pack colour, believing that 'silver', 'gold' and 'white' brands are less harmful to smoke than 'black' or 'red' brands. The reason for those beliefs may lie in the history of cigarette branding. Cigarettes used to carry labels like 'light', 'mild', and 'low tar', and in some places they still do. But in over fifty countries cigarette manufacturers are no longer allowed to use those labels because they are misleading. In some cases, cigarette manufacturers simply changed their 'light' cigarettes to 'silver' and 'gold' brands -- for example, Marlboro Lights has become Marlboro Gold. A significant percentage of smokers now seem to equate those colours with low-risk cigarettes."

According to the Campaign for Tobacco-Free Kids, two of the major public health victories from the passage of the FDA tobacco legislation -- which were supposed to save "countless lives" -- were the ban on flavored cigarettes and the ban on the use of descriptors like "light" and "low-tar" that mislead consumers into believing that these cigarettes are safer.

But one by one, these (false) promises have come tumbling to the ground.

First, it was the promise that the ban on flavored cigarettes would break the cycle of addiction by helping to end the tobacco industry's ability to addict our nation's children. The Campaign wrote that: "The ban on candy and fruit-flavored cigarettes is a critical step to end one of the most insidious tactics the tobacco industry has used to target and addict children."

But the truth came out: not a single product produced by Philip Morris, R.J. Reynolds, or Lorillard was affected by the cigarette flavoring ban, very few youths smoke products that are affected by the ban, and in the entire cigarette market, less than 0.2% of all cigarettes consumed are flavored cigarettes covered by the ban. The truth is that far from being a critical step to halt addiction, this aspect of the law does literally nothing to protect kids from addiction.

Now, it is the promise that the ban on descriptors such as "light" and "low-tar" will eliminate the deception of consumers, who are led to believe that these products are safer because of this terminology.

So far, the Family Smoking Prevention and Tobacco Control Act has not done a single thing to substantially protect the public's health. It has done nothing to reduce youth smoking. It has done nothing to promote smoking cessation. And it has done nothing to make cigarettes safer.

It has, however, detracted attention and resources away from the proven measures that would have helped protect the public's health and actually save lives: allocating money to anti-smoking media campaigns in all 50 states.

Perhaps second only to the Master Settlement Agreement, I believe that the Family Smoking Prevention and Tobacco Control Act represents one of the greatest public health policy disasters of my lifetime.

Tuesday, April 19, 2011

A new study published in this month's issue of the Archives of Pediatrics and Adolescent Medicine concludes that secondhand smoke exposure among children causes mental illness, including depression, attention deficit disorder, and conduct disorder (see: Bandiera FC, Richardson AK, Lee, DJ, He J-P, Merikangas KR. Secondhand smoke exposure and mental health among children and adolescents. Archives of Pediatrics and Adolescent Medicine 2011; 165(4):332-338).

The research involved a cross-sectional study of the relationship between secondhand smoke exposure, measured by serum cotinine levels, and symptoms of mental illness based on data from the National Health and Nutrition Examination Survey in 2001 through 2004. The researchers found that: "Among nonsmokers, serum cotinine level was positively associated with symptoms of DSM-IV major depressive disorder, generalized anxiety disorder, attention-deficit/hyperactivity disorder, and conduct disorder after adjusting for survey design, age, sex, race/ethnicity, poverty, migraine, asthma, hay fever, maternal smoking during pregnancy, and allostatic load."

The article concludes: "The findings presented herein provide additional evidence on the harmful effects of SHS exposure on children and adolescents. Our results are consistent with data from previous cross-sectional and prospective studies in adults and suggest that exposure to SHS may precipitate the onset of or exacerbate mental disorder symptoms."

The Rest of the Story

The glaring limitation of this study is that it failed to control for mental health problems among the children's parents, which have been demonstrated to be associated both with smoking and with mental health problems among their children. Thus, this is a likely confounder of the observed association between secondhand smoke exposure and mental health problems among children and adolescents.

This flaw does not invalidate the overall finding of an association between secondhand smoke exposure and mental health problems in children, but it does preclude a conclusion that it is the secondhand smoke exposure that is causing the mental health problems. It may simply be that parents with mental health problems are both more likely to smoke and more likely to have children with mental health problems.

What is most striking about this article, however, is not any of the above. What is most striking is that the authors acknowledge this limitation, yet they still conclude that there is a causal relationship between secondhand smoke exposure and mental health problems in children.

The authors write: "Another potential confounder that we were unable to control for in our analysis is maternal psychiatric history. That is, children with depressed mothers are more likely to have poor mental health." They cite three studies which demonstrate an association between mental health problems in children and mental health problems in their mothers.

Despite this limitation, however, the authors go on to conclude that the association observed in the study is a causal one ("The findings presented herein provide additional evidence on the harmful effects of SHS exposure on children and adolescents.") In fact, they go so far as to suggest that if parents smoke outside the home, it will lower population rates of mental illness.

There is nothing wrong with publishing a study that has limitations. The art of research, however, is drawing solid conclusions given the limitations in your study. In this case, one wonders why the authors have drawn a causal conclusion despite the major limitation in the methodology, which they readily acknowledge and highlight for the reader. Unfortunately, it leaves the impression that the researchers had a pre-determined conclusion and that they reached this conclusion regardless of the strength of the actual scientific evidence.

As my readers know, this is not an isolated case. For some reason, many recent studies on secondhand smoke appear to fall into this category. For this reason, I have come to the conclusion that the scientific rigor in the tobacco control movement has deteriorated. Investigators seem so determined to demonstrate the adverse effects of secondhand smoke that they overlook their own clearly stated assertions and conclude that there is an effect of secondhand smoke anyway, despite their own acknowledgment that such a conclusion is unwarranted based on the evidence.

Monday, April 18, 2011

You are a non-profit organization that is involved in lobbying all 50 state legislatures. You do not produce or market any products so you are not making any direct contribution to the nation's obesity problems. However, your lobbying efforts are directed against legislation to improve school nutrition standards, limit the availability of soda and junk food in schools, and reduce the consumption of junk food and soda.

You approach the National Heart, Lung, and Blood Institute (NHLBI) - nation's leading federal agency fighting heart disease (and therefore obesity) - and ask if you can be recognized by this federal agency as a partner in the national effort to reduce heart disease. You also approach the American Cancer Society with the same request.

Then, you go for broke. You ask the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians to also endorse you as a full-fledged partner in the national effort to reduce childhood obesity.

When these organizations question you about your activities, you are honest and reveal that you actively lobby against legislation in all 50 states to improve school nutrition standards, limit the availability of soda and junk food in schools, and reduce the consumption of junk food and soda. You acknowledge that you are even lobbying against basic environmental health policies like bottle bills, which are supported by even the most conservative groups.

You also acknowledge that when advocates in one state attempted to set nutrition guidelines on food and beverages, you hired a lobbying firm to gut the law. "The political struggle included an eight-hour House debate in which lawmakers engaged in stall tactics and delayed the process by adding unrelated amendments. [Your] lobbyists also shared data regarding school income from soda sales with lawmakers behind closed doors so that nutrition advocates could not refute the information. [You] also delivered a well-stocked cooler [of Coca-Cola] to the Democratic caucus room just before the House was expected to vote on the bill." (Source: Michele Simon. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006)

In 2010 alone, you spent $4.9 million dollars lobbying against public health legislation, of which nearly a half million went to seven private lobbying firms. You also donated money to a front group which runs attack campaigns against public health and nutrition groups. The front group that you fund is run by an organization that also funds efforts to prevent stricter drunk driving legislation.

Do you think you would have a prayer in hell of ever getting the National Heart, Lung, and Blood Institute, the American Cancer Society, the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians to endorse you as a full-fledged partner in the effort to fight childhood obesity and improve the public's health?

Probably not, but that isn't the actual scenario in question.

The actual scenario is as follows:

Everything above is true, including:

your lobbying against legislation in all 50 states to improve school nutrition standards, limit the availability of soda and junk food in schools, and reduce the consumption of junk food and soda; your lobbying against basic environmental health policies like bottle bills, which are supported by even the most conservative groups;

your hiring a law firm to gut a state bill to improve school nutrition standards;

your delivering a cooler of Coca-Cola to the Democratic caucus room just before the vote;

your spending $4.9 million dollars lobbying against public health legislation, of which nearly a half million went to seven private lobbying firms; and

your donating money to a front group which runs attack campaigns against public health and nutrition groups and which is funded by an organization that also funds efforts to prevent stricter drunk driving legislation.

However, on top of all of this, you also are the actual producer and marketer of soda that is actually contributing to the nation's obesity problem. A single bottle of your most popular product delivers a whopping 46 grams of sugar in a single serving.

Now, if you didn't think you would have a prayer in hell of ever getting the National Heart, Lung, and Blood Institute, the American Cancer Society, the American Dietetic Association, the American Academy of Pediatrics, and the American Academy of Family Physicians to endorse you as a full-fledged partner in the effort to fight childhood obesity and improve the public's health before, what kind of chances do you think you'd have now?

On top of all your lobbying against policies to improve school nutrition and reduce junk food and soda consumption, on top of your millions of dollars of lobbying expenditures to fight public health and environmental health policies, and on top of your donations to an organization that is tied to even the most sensible policies like strict drunk driving laws, you are the leading producer of the actual soda that is contributing significantly to the obesity problem.

The Rest of the Story

The rest of the story is that this scenario actually occurred (see Michele Simon. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006), and that the corporation involved - the Coca-Cola Company - was successful in buying off the endorsements of the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians, as I detailed last week. In addition, as I reveal today, this corporation was successful in gaining similar endorsements and partnerships from the federal government - the National Heart, Lung, and Blood Institute (NHLBI) - and a health charity group: the American Cancer Society. Sadly, these organizations were also bought off by monetary donations, allowing Coca-Cola to achieve the unimaginable feat of opposing even basic school nutrition standards by being recognized by the NHLBI and the American Cancer Society as being a leader in the movement to reduce heart disease by controlling obesity.

1. The American Cancer Society

The American Cancer Society acknowledges that it receives support from the Coca-Cola Company for its Choose You campaign. This is a campaign to promote healthy living, including eating right and maintaining good nutrition.

The American Cancer Society was bought off into endorsing as a corporate partner a company that opposes improving school nutrition standards and opposes measures to limit infants' exposure to bisphenol-A, a possible carcinogen to which the ACS publicly states people should limit their exposure. What a fine choice for a partner!

To make matters even worse, the American Cancer Society misleads the public by stating that it will not partner with any company whose products contribute to obesity. Clearly, it is violating its own stated criteria here. The ACS claims: "If a product contributes to obesity, a major contributor of cancer, it's out." So much for honesty.

While the ACS might try to argue that it is really just Diet Coke and Sprite Zero which are sponsoring the Choose You campaign, that is hogwash. There is no such company as Diet Coke or Sprite Zero and the corporate sponsor is the Coca-Cola Company, not Diet Coke or Sprite Zero. The Coca-Cola Company does indeed produce products that contribute to obesity, so the American Cancer Society's claim is a bunch of baloney.

I'll have to remember this trick. The next time I need money for my anti-smoking research, I'll ask Philip Morris. But I'll publicize the sponsorship of my research as coming from Chateau Ste. Michelle wine (another product of Altria, in addition to Marlboro cigarettes). I can then declare on my web site: "I refuse to accept any sponsorship of my research from any product which contributes to tobacco-related disease." That way, I can have my cake and eat it too. I can claim to be following science-based, ethical standards.

That the American Cancer Society is relying on such flimsy and totally bogus reasoning to defend this sponsorship is actually worse than the sponsorship itself. Why? Because the organization is essentially lying to the public. It's a huge hoax that they are pulling on their own constituents, volunteers, and donors. Frankly, it's sickening to see how low the ACS has sunk with this cheap ploy.

2. The National Heart, Blood, and Lung Institute

Apparently in return for its donation to the Foundation for the National Institutes of Health, the NHLBI agreed to allow Coca-Cola to be a partner in its Heart Truth campaign. By allowing Coca-Cola to be a partner, the NHLBI has allowed Coca-Cola to boast on its web site that: "Our research with consumers has told us that women today are increasingly mindful of making choices that positively impact their lives. For them, drinking Diet Coke is an essential part of their modern pursuit of well-being." OK then. I didn't realize that the NHLBI was in the business of marketing Diet Coke.

But these natural-cut fries are actually just as unhealthy as the old ones. In fact, they deliver 10 more calories, delivering a whopping 420 calories, 20 grams of fat, 500 milligrams of sodium, and 54 grams of carbohydrates. These all make it less healthy than the original fries.

Whether it likes it or not, through its partnership with Coca-Cola, the NHLBI is actually helping to promote and market Wendy's new natural-cut fries at 420 calories and a half gram of sodium per serving. What kind of contribution is that going to make to the NHLBI's goal of reducing hypertension, obesity, and heart disease?

And don't give me the same argument that it is actually Diet Coke, and not Coca-Cola, that is sponsorship the campaign. Diet Coke is not a company, and the NHLBI knows full well that it is the Coca-Cola Company which is sponsoring the campaign and getting a huge marketing opportunity from it - not only for Diet Coke but for its entire line of products, including Coke itself, which is prominently displayed in an advertisement on the web site that was touted as providing information on the Little Red Dress program.

So now we have even more to the rest of the story. The company which the American Dietetic Association and American Academy of Pediatrics tout as being a leader in the national movement to curb childhood obesity is actively promoting fast food - specifically, french fries.

Does the NHLBI really want to be marketing french fries to the public? Through its partnership with Coca-Cola, it is unfortunately also partnering in this marketing of french fries. Unfortunately, there's no such thing as partnering with just "Diet Coke." If you partner with Coca-Cola, you get the whole shebang. And that includes the promotion of 420 calorie per serving french fries.

And, might I add, that's only a side dish. You're getting 420 calories and half a gram of salt from a side dish alone. The most basic item at Wendy's - it's 1/4 pound burger - delivers 550 calories, 28 grams of fat, and 1.28 grams of sodium. Yes, you read that right - 1.28 grams of sodium.

I do think it's time for the American Cancer Society and the NHLBI to re-examine their criteria for corporate partnerships.

Not only is the NHLBI helping to market french fries, but it is directly helping to market soda.

Frankly, I don't think that Coca-Cola really needs this help in marketing its products from the NHLBI and American Cancer Society. The company seems to be doing pretty well on its own, selling 1.4 billion servings of its beverages each day.

Now all we need is a federal agency or cancer organization that will actually help fight obesity, heart disease, and cancer, rather than help promote and market products that contribute to these problems.

SOURCE: Most of the information upon which this post is based comes from the following source -- Michele Simon. Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back. New York: Nation Books, 2006

Friday, April 15, 2011

I have written extensively this week on the corporate partnerships that three public health organizations - the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Dietetic Association - have forged with Coca-Cola and other Big Food companies and how these partnerships aid the marketing plans and marketing efforts of these companies, undermine the integrity and public health mission of these supposedly public health-committed organizations, and directly undermine the public's health itself by helping to market unhealthy products.

Although I have been the target of many personal attacks due to my coming out publicly with these opinions, it is clear to me that I have struck a nerve somewhere and that the defensive reaction is due to an underlying realization that these corporate partnerships are not sustainable if these organizations are to retain any semblance of integrity.

I want to close the week by putting forward two pieces of evidence that demonstrate why these partnerships are unacceptable.

1. Coca-Cola and other Big Food companies are using these partnerships to enhance their corporate image, and therefore, their bottom line: sales of unhealthy products that are contributing towards the nation's obesity epidemic.

In its 2010 annual report, Coca-Cola writes: "Obesity and other health concerns may reduce demand for some of our products. Consumers, public health officials and government officials are becoming increasingly concerned about the public health consequences associated with obesity, particularly among young people. In addition, some researchers, health advocates and dietary guidelines are encouraging consumers to reduce consumption of sugar-sweetened beverages, including those sweetened with HFCS or other nutritive sweeteners. Increasing public concern about these issues; possible new taxes and governmental regulations concerning the marketing, labeling or availability of our beverages; and negative publicity resulting from actual or threatened legal actions against us or other companies in our industry relating to the marketing, labeling or sale of sugar-sweetened beverages may reduce demand for our beverages, which could affect our profitability."

Thus, Coca-Cola directly acknowledges that a negative public image impacts its bottom line - profits - and therefore, that improving its public image will do the opposite: increase Coke sales.

In its 2010 Sustainability Report, Coca-Cola makes it clear that it is using the ADA, AAP, and AAFP to improve its public image by reaching millions of consumers. It boasts about how responsible a company it is due to its partnership with these organizations: "In the United States, we currently reach millions of consumers annually through our work with the American Dietetic Association; the National Heart, Lung, and Blood Institute’s The Heart Truth® campaign; the American Cancer Society’s Choose You™ campaign; the American College of Sports Medicine; the Preventive Cardiovascular Nurses Association; and the American Academy of Family Physicians."

Pepsico, in its 2010 annual report, also makes clear the connection between the company's public image and its bottom line: "Damage to our reputation or loss of consumer confidence in our products for any of these or other reasons could result in decreased demand for our products and could have a material adverse effect on our business, financial condition and results of operations, as well as require additional resources to rebuild our reputation."

2. The American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians are supporting companies that oppose virtually every state-specific public health policy related to improvement of school nutrition, reduction of junk food and soda consumption, and environmental health and safety.

Regardless of its public statements, Coca-Cola is clearly opposed to virtually all state legislation proposed by public health groups to improve school nutrition and reduce the consumption of unhealthy, sugar-sweetened beverages.

To be clear: "GMA submitted testimony in opposition to mandated school nutrition standards."

That the American Dietetic Association, American Academy of Pediatrics, and American Academy of Family Physicians can claim that Coca-Cola is committed to improving childhood health in the face of this company's opposition to even the most basic school nutrition standards is, in my opinion, despicable.

And whether they like it or not, through their support of Coca-Cola, the ADA, AAP, and AAFP are supporting a company that opposes school nutrition standards. Moreover, by supporting Coca-Cola, they are shooting themselves in the foot because whether they like it or not, their corporate partnerships are actually working to: oppose any and all taxes on sugar-sweetened beverages (soft drinks), oppose the removal of BPA from bottles containing liquids consumed by infants, oppose legislation to simply require the disclosure of product ingredients, oppose taxes on candy, oppose bottle bills, oppose all restrictions on BPA-containing packaging, oppose standards for food processing, and oppose school nutrition standards.

Despite the public statements of Coca-Cola about how it is committed to improving school nutrition, when it really comes down to it, the company is opposed to every reasonable measure - even the most basic school nutrition standards. Just like the tobacco companies used to do, Coca-Cola is talking out of one side of its mouth, and out of the other, it is working behind the scenes to oppose the very measures that it purports to support.

That the AAP, AAFP, and ADA have fallen for Coca-Cola's tricks is one possibility. The other, which I find more likely, is that they have been bought off. In other words, that the receipt of large amounts of money has caused them to look the other way. It's amazing what a little financial support will do. And of course, this is precisely the reason why companies like Coca-Cola and Pepsico include the sponsorship of public health organizations in their marketing plans.

Thursday, April 14, 2011

While I received many responses from American Dietetic Association (ADA) members who shared their personal opinion that the ADA should discontinue its sponsorship by the Coca-Cola Company and Pepsico, a few members defended these sponsorships. Their main argument was that although these companies market unhealthy products like Coke and Pepsi that are contributing to the obesity epidemic, they also market healthy products.

One ADA member wrote: "the companies you criticize have a wide variety of products available from good for you to more indulgent. These companies employ many of the best scientists in the world because they want to make a difference in providing healthier options to consumers."

Another wrote: "Both Coca Cola and Pepsi are massive companies that represent a multitude of brands. According to Cokes own website they have 3500 different brands in over 200 countries including water, fruit juice and soy beverages. Pepsi's brands include Frito Lay, Tropicana, and Quaker. Everyone focuses on the "worst" of these brands, the high calorie sodas, but seems to ignore all of the other possibilities within both Pepsi and Coke."

The Rest of the Story

One could make the exact same argument about Big Tobacco. But can you imagine if an anti-smoking group which accepted money from tobacco companies had defended these sponsorships by arguing that although Altria (maker of Marlboro, Virginia Slims, Basic, and Merit) markets Marlboro cigarettes, it also produced Balance Bars, Boca Burgers, Grape Nuts cereal, Shredded Wheat, and Light n' Lively yogurt. Sure Altria markets deadly cigarettes, but it also marketed healthy products such as nutritious cereals and yogurt and even vegetable burgers - a very healthy alternative to beef burgers.

Can you imagine the Campaign for Tobacco-Free Kids ever defending corporate funding from R.J. Reynolds (when it owned Nabisco) by arguing that although R.J. Reynolds makes Camel cigarettes, they also market very healthy snacks, including Wheat Thins, Stoned Wheat Thins, and Wheatsworth crackers?

When Coca-Cola drops its marketing of Coke and only sells its healthy line of products, then you can talk to me about how Coca-Cola is promoting the public's health.

When Coca-Cola stops lobbying against policies to improve school nutrition, then you can talk to me about how this corporation is promoting health.

The truth is, Coca-Cola and Pepsico are working directly against our public health goals. They are lobbying vigorously against even the most basic policies to improve school-based nutrition, policies that are supported by virtually every public health organization.

By supporting Coke and Pepsi's marketing plans, the ADA is literally shooting itself in the foot. It is supporting companies that are lobbying against improved school nutrition. It is partnering with an enemy of improved nutrition for school children.

That bears repeating. The ADA is partnering with an enemy of improved nutrition for school children.

As Michele Simon pointed out, Coca-Cola and Pepsico are "on record as opposing virtually every state bill across the nation that would restrict the sale of junk food or soda in schools."

What great companies for the ADA to be partnering with.But I guess that's OK, because Coca-Cola also sells Gold Peak green tea and Pepsico also sells Tropicana orange juice.

Wednesday, April 13, 2011

The American Academy of Family Physicians (AAFP) has entered into a corporate partnership with the Coca-Cola Company, in which Coca-Cola is providing money to AAFP in return for public recognition, improvement of its public image, distraction of public attention away from the role of Coca-Cola's products in the obesity epidemic, a lucrative marketing opportunity for Coke, and ultimately, an increase in its bottom line (Coke sales).

The large expenditure on the part of Coca-Cola is very well spent, and should be applauded vigorously by Coca-Cola stockholders. The corporation is already starting to reap the benefits of this rare marketing opportunity.

On the web site that is apparently being supported by Coca-Cola, the AAFP actually goes so far as cautioning people not to necessarily limit their consumption of soda: "Sugar-sweetened drinks, such as fruit juice, fruit drinks, regular soft drinks, sports drinks, energy drinks, sweetened or flavored milk and sweetened iced tea can add lots of sugar and calories to your diet. But staying hydrated is important for good health."

This sounds like a statement coming right out of the mouth of Coca-Cola itself. The company repeatedly refers to its sugar-laden soft drinks as a way of meeting your "hydration needs."

It's quite interesting that the AAFP does not say: "Sugar-sweetened drinks, such as fruit juice, fruit drinks, regular soft drinks, sports drinks, energy drinks, sweetened or flavored milk and sweetened iced tea can add lots of sugar and calories to your diet. To stay well-hydrated, make sure to drink plenty of water, as water keeps you hydrated without adding extra calories."

Whatever Coca-Cola paid for achieving the actual statement made by the AAFP instead of the alternative statement that is actually the appropriate public health statement was well worth the expenditure. To get the nation's body of family physicians to caution people against limiting their soda intake is more than money could ever be expected to buy. The Coca-Cola executives who made this deal with AAFP must be laughing in their accomplishments.

Coca-Cola does not deserve all the credit here. The AAFP also accepts marketing expenditures (i.e., corporate sponsorship money) from Pepsico as well. Coca-Cola is listed as a Grand Patron, while Pepsico contributes at the "Sustaining" level.

The American Academy of Family Physicians is not the only physician group that has prostituted itself and sold out its values and integrity by lending its good name to the marketing efforts of Coca-Cola.

In 2010, the president of the American Academy of Pediatrics (AAP) helped Coca-Cola market its products by participating in Coke's sponsorship of the 2010 Olympic Torch relay. Not to be outdone, she was joined by a member of the American Academy of Family Physicians and the president of the American Dietetic Association. These health professionals stood shoulder-to-shoulder with top Coca-Cola sales and marketing executives in this major effort to promote Coke internationally.

Do you think it is any coincidence that Coca-Cola found a way to choose prominent representatives from the AAP, AAFP, and ADA? Of course not. The obvious purpose of this marketing ploy was to associate the good name of these organizations with Coke and to help deter potential role of these organizations in calling for policies that would hurt Coke sales. This is sheer marketing brilliance!

More impressively and reeking with irony, the American Academy of Pediatrics accepted funding from Coca-Cola to sponsor its "Healthy Children" web site. On that site, the AAP states that the Coca-Cola Company is committed: "to better the health of children worldwide."

Whatever Coca-Cola contributed to the American Academy of Pediatrics to garner that statement and recognition as a leader in the child health movement internationally was nowhere near enough. This is blatant prostitution, where the AAP is essentially selling its site to the highest bidder. Do you want to be recognized as a leader in children's health internationally? Simply pay off the AAP. Never mind the fact that you market a product which is a major contributor toward childhood obesity.

And never mind the fact that it was alleged that your company was selling products with high levels of pesticides to rural villagers in India. According to Source Watch: "In August 2003, the Centre for Science and Environment had announced that a dozen drinks, produced by both Coca-Cola and Pepsi, contained unacceptably high levels of pesticides. However, if the formation of the advisory committee was designed to deflect attention, it was of little help when two days after its first meeting the Kerala high court ordered the company to stop extracting groundwater for its bottling plant near Plachimada village. The ruling followed a 608 day long protest by local villagers who complained the water extraction by Coca-Cola was so great it was drying their rice paddies out and killing their coconut palms."

Moreover, the very company that the AAP describes as an international leader in children's health lobbied vigorously against legislation that would have improved school nutrition in Connecticut.

According to Source Watch: "Connecticut Governor Jodi Rell vetoed what would have been the nation's strongest school-based nutrition law in June 2005, a bill that would have allowed only water, juice, and milk to be sold during the school day, K-12. In 2004, advocates had attempted to set nutrition guidelines on food and beverages, but lobbying by Coke and PepsiCo gutted the law. Coke hired Patrick Sullivan of Sullivan & LeShane to lobby on its behalf. The political struggle included an eight-hour House debate in which lawmakers engaged in stall tactics and delayed the process by adding unrelated amendments. Coke lobbyists also shared data regarding school income from soda sales with lawmakers behind closed doors so that nutrition advocates could not refute the information. Coke also delivered a well-stocked cooler to the Democratic caucus room just before the House was expected to vote on the bill."

And this is the company that the AAP tells us is an international leader in the protection of children's health. These physicians should be completely ashamed of themselves.

Rosenberg and I explained, in a 2009 article in Tobacco Control, how corporate sponsorship plays a critical role in marketing by enhancing the public image of the company, which enhances its bottom line -- product sales: "Through its corporate sponsorship, a ... company may be able to create good will among the public ... it may help put a “human” face on the corporation and point out its contributions to the community, taking the focus away from damage caused by its products." In turn, this helps the company stave off policy changes that would improve the public's health by reducing the sale of its unhealthy products.

By accepting these sponsorships from the leading manufacturers of sugar-laden soft drinks that are contributing to the nation's obesity epidemic, by playing a role in the marketing of these products, and by actively promoting these companies as international leaders in children's health, the American Academy of Family Physicians and American Academy of Pediatrics are butchering the Hippocratic Oath that all of its physician members took. Rather than "doing no harm," these sponsorships are doing tremendous harm to the protection of the public's health by helping these massive corporations market their unhealthy products.

Tuesday, April 12, 2011

On its web site, the American Dietetic Association (ADA) claims to be "your source for trustworthy, science-based food and nutrition information." The ADA also claims that it "is committed to improving the nation's health and advancing the profession of dietetics through research, education and advocacy."

One aspect of the ADA's web site is its corporate sponsorship program where it welcomes select groups (which provide it with donations) to the "health community."

The American Dietetic Association acknowledges that its corporate sponsorship program allows corporate sponsors to "Reinforce and elevate your position as a leader in health and wellness."

The Rest of the Story

Two of the ADA's corporate sponsors -- companies which the ADA is therefore promoting as being leaders in health and wellness -- are the Coca-Cola Company (manufacturer of Coke) and Pepsico (maker of Pepsi) .

So much for the ADA's ability to deliver "trustworthy" and "science-based" food and nutrition information. You simply can't do that when you're receiving funding from companies that are marketing some of the most unhealthy snacks and beverages imaginable. Even if acting only subconsciously, these sponsorships are going to temper the information that the ADA provides about the unhealthiness of drinking Coke and Pepsi. Moreover, the sponsorship gives these corporations the opportunity to make it look like they are committed to the nation's health, thus obscuring attention from the contributions their products are making to the obesity epidemic.

The ADA honored the Coca-Cola corporation with this press release announcing their partnership. In the release, the ADA readily acknowledges that one of the purposes of the sponsorship is to give Coca-Cola "prominent access to key influencers, thought leaders and decision makers in the food and nutrition marketplace."

In this press release, the American Dietetic Association allows Coca-Cola to tell the public that its sugar-laden soft drinks are designed to "meet their hydration needs." The ADA also describes Coca-Cola as being committed to: "product innovation and nutrition education, helping to meet changing consumer wellness needs through beverages and serving as a resource for health professionals and others interested in the science of beverages and their role in healthful living."

Thus, on its own web site, the ADA is promoting Coke - a sugar-laden soft drink - as being valuable for meeting people's "hydration needs."

Coca-Cola and Pepsico are certainly getting their monies worth from their sponsorship of the ADA.

For example, the ADA has published a lengthy document about improving nutritional standards in schools, but nowhere in the document does it recommend banning soda vending machines. The document goes into unproven, marginal strategies such as garden-based education, but it ignores evidence-based strategies such as soda taxation or removal of soda from schools.

Moreover, nowhere on the ADA's web site does it recommend the taxation of soda and junk food, restrictions on soda marketing in schools, or removal of soda and junk food vending machines as strategies to improve school and childhood nutrition. Taxation of soft drinks is an evidence-based strategy to address obesity that is widely supported by public health groups.

To add insult to injury, the ADA's healthy eating tip sheet does not recommend that people moderate their soda intake.

According to a post over at the Healthy Eating Politics blog: "In her book, Food Politics, Marion Nestle, a Professor of Nutrition, Food Studies, and Public Health at New York University, wrote:"

"The ADA's stance on dietary advice is firmly pro-industry; one of its basic tenets is that there is no such thing as a good or a bad food. The Association is apparently willing to enter into partnerships with any food company or trade organization, regardless of the nutritional quality of its products."

On the ADA's own web site, the Coca-Cola Company boasts about its sponsorship of the American Dietetic Association and how Coca-Cola is committed to promoting the public's health by helping people to meet their "hydration" needs: "We are proud to partner with the American Dietetic Association, one of the country's leading authorities in health and nutrition education. Our partnership with the American Dietetic Association is central to our efforts to continually provide consumers with innovative options that meet their hydration needs and ever-changing tastes and information that allows them to make informed decisions about their personal wellbeing. Like ADA, Coca-Cola understands that a healthy lifestyle involves balancing many different elements — staying physically active, consuming a balanced diet, getting enough rest — and even keeping a positive attitude."

Thanks to the ADA, the Coca-Cola Company is getting a huge public relations benefit and a rare and unique opportunity to improve its public image and obscure attention away from the contribution of its products to poor nutrition and obesity.

In its annual sustainability report for 2009-2010, the Coca-Cola Company uses its sponsorship of the American Dietetic Association to enhance its own public image as a socially responsible company that is committed to improving the public's health. Coca-Cola writes: "We continue to build public-private partnerships to promote the importance of energy balance that includes physical activity and sensible, balanced diets. In the United States, we currently reach millions of consumers annually through our work with the American Dietetic Association... ."

Pepsico, too, uses its sponsorship of the American Dietetic Association to enhance its image as a socially responsible company that is working to improve the public's health. In its 2008 annual sustainability report, it writes: "In the U.S., we’re working with the American Dietetic Association, the nation’s largest organization of food and nutrition professionals, to develop educational programs and engage in frequent dialogues that will make a positive difference in public health through improved product choices and adoption of active lifestyles."

For Coca-Cola and Pepsico, corporate sponsorship is actually part of their marketing mix. Sponsorship is an aspect of public relations, which is one of the four elements of corporate marketing: advertising, sales promotion, public relations, and direct marketing.

As Rosenberg and I wrote in an article in the journal Tobacco Control in 2001: "Corporate sponsorship of events and organisations is a well recognised marketing tool. In the marketing literature, sponsorship is noted to enhance a corporation’s image, to associate the name of a sponsoring company with causes that are important to a particular target group, to offer effective product exposure, to target specific populations including groups that are difficult to reach through more traditional forms of advertising, and to provide publicity for a company through highly visible activities. Corporate sponsorship of, and donations to, social causes has been termed “cause related marketing” and its purposes, according to Kotler, are to “enhance corporate image, thwart negative publicity, pacify consumer groups, launch a new product or brand, broaden their customer base, and generate incremental sales” (page 29)."

As we noted, the purpose of corporate sponsorships is "to promote brand and company awareness, to develop brand and company associations with attractive images, to create co-marketing opportunities by allowing them to combine advertising with sponsorship in promotion of a product image, and to enhance their public image by achieving recognition as good corporate citizens. Each of these functions is well recognised in the marketing literature as a major objective of corporate sponsorship."

Thus, by accepting corporate sponsorships from companies like Coca-Cola and Pepsico, the American Dietetic Association is not only compromising its own scientific and public health integrity, it is also serving as a pawn in the marketing plans of these companies, allowing them to further promote the very products which are in part responsible for the obesity epidemic.

The American Dietetic Association, therefore, is actually helping to market soda and other unhealthy products, undermining its entire public health goal.

The rest of the story is that the American Dietetic Association has prostituted itself, its scientific integrity, and its commitment to the public's health by accepting corporate sponsorships from the Coca-Cola Company and Pepsico and allowing itself to be used to help market products which are contributing substantially to the very problem that the ADA purports to be confronting.

To make matters even worse, the ADA has accepted corporate sponsorships from a host of other corporations which are also marketing unhealthy foods - such as candy and junk food - which are contributing to the nation's obesity epidemic. These companies include Con-Agra, which markets Wesson vegetable oil for use in frying foods, Slim Jim Beef & Cheese "snacks," and Kid Cuisine All American Fried Chicken.

Just how much of a contribution is Con-Agra making to the health of our nation's children by marketing Kid Cuisine All American Fried Chicken, and how much of a contribution is the ADA making by helping Con-Agra to market this product?

Well, let's look at the nutritional information for a single serving of Kid Cuisine: it contains 540 calories, a whopping 24 grams of fat, 210 fat calories, 1 gram of trans-fat, and 750 mg of sodium. Is this really the kind of product behind which the ADA wants to ally itself? Is this really the type of product that the ADA wants to help market to the nation's children?

A single serving of Slim Jim Beef & Cheese "snack" delivers a whopping 630 mg of sodium, along with 100 fat calories and a half gram of trans-fat. Is this really a product that the ADA wants to help market as nutritious snack food?

Whether it intends to or not, through its Pepsico sponsorship, the ADA is actually helping the company market its Captain Crunch cereal to America's children, which in just a 3/4 cup serving delivers 11.8 grams of sugar. Is this the ADA's idea of a healthy breakfast for a child?

Also through its Pepsico sponsorship, the ADA is helping Pepsico to market its 2-ounce Flamin' Hot Cheetos snack, which delivers 340 calories and 22 grams of fat to a child in a single serving.

And this is just the beginning. The ADA is running a virtual brothel of corporate sponsorships, in which it is completely prostituting its scientific and public health integrity by enabling the marketing efforts of many of the companies making the very products which are least nutritious.

Take its Mars Company sponsorship. Does the ADA really want to help market the Snickers bar as a nutritious snack, when a single bar delivers to a child 280 calories, 14 grams of fat, and a whopping 5 grams of saturated fat?

And what about its sponsorship by Cargill? Just how nutritious is Cargill's Sterling Silver chuck beef burger, which delivers 230 calories, 16 grams of fat, and a full gram of trans-fat in a single patty?

The American Dietetic Association has lost its ability to provide unbiased and trustworthy nutrition information and recommendations to the public. It has also lost its credibility in making recommendations for public health policy. Worst of all, it is actually contributing to, rather than confronting, the nation's obesity epidemic by serving as a marketing tool for the very corporations whose products are most responsible for poor nutrition and obesity, especially among our nation's children.

NOTE (April 12, 2010 - 1:00 pm): The ADA's sponsorship by Con-Agra is acknowledged here. The funding is for the 2011 Food & Nutrition Conference & Expo in San Diego in September. The conference would more aptly be named: "The 2011 ADA Slim Jim Beef & Cheese Conference."

Monday, April 11, 2011

In 90 days, smoking in cars with children under 14 years old will be illegal in Arkansas, thanks to legislation enacted by the state legislature last week. It is already illegal to smoke in cars with infants and children under age 6; the legislation extends the ban to include smoking in cars with children up to age 13.

According to an article on the KSPR (Springfield, Missouri ABC affiliate) web site: "90 days from now your vehicle will not longer be your castle, if you will. Arkansans already can't smoke in the car if a child in a car seat is a passenger; Arkansas legislators say tweaking that law will spare more than 270,000 children from exposure to secondhand smoke."

According to another article, the director of the Arkansas Department of Health supported the law, stating: "Perhaps some of the worst exposure is in an automobile."

The legislation was widely supported by anti-smoking groups, including the American Cancer Society, which advocates state laws banning smoking in cars with children under age 18.

The Rest of the Story

The truth is that this law will not spare 270,000 children from secondhand smoke exposure. It may spare them from exposure during the minutes they are in a car, but it will not spare them exposure during the hours upon hours that they are in the home.

If these groups are sincere about standing up to protect the health of children, and if they are willing to interfere with parental autonomy in private vehicles by banning smoking in those vehicles, then why are these groups not proposing or supporting bans on smoking in the home? After all, the home - not the car - is the greatest source of secondhand smoke exposure for children who live with smokers.

The state health department director is mistaken in arguing that the worst exposure is in the car. He is confusing concentration of exposure with dose. The dose of exposure is equal to the concentration of exposure multiplied by the duration of exposure:

Dose = Concentration x Duration

While the concentration of secondhand smoke in cars can be very high, the duration of this exposure is short compared to the duration of exposure in the home. And you can bet that if parents are smoking in cars with children, they are most likely also smoking in the home.

By not supporting a ban on smoking in homes with young children, I believe that these politicians, policy makers, and anti-smoking groups are actually being hypocritical and displaying a lack of sincerity, as well as a subordination of public health protection to politics.

My own position is that although smoking in cars with children is unfortunate, the government should not interfere with parental autonomy to make decisions about their children's health risks unless those risks are immediately life-threatening (such as not wearing a seat belt or car seat) or if the behavior causes harm to the child (e.g., abuse or neglect). I do not support smoking bans in the home for this reason. However, I also do not support bans on smoking in cars for the same reason. It would be hypocritical of me to argue for smoking bans in cars with children, but to oppose such policies in homes with children.

Sometimes the most difficult decisions in public health are ones in which we must accept the fact that many parents put their children at risk of health problems. We can still intervene to try to prevent this from happening with educational and persuasion campaigns, but coercive measures that interfere with parental autonomy when the child is not in a situation of direct, life-threatening risk or actual harm are not justified.

While the policy makers and health groups supporting the smoking ban in cars with children are well-intentioned, I believe they are also being insincere in their stated intention of protecting the health of these children. They want to protect them from high, but short-term exposure in cars, but they are perfectly willing to subject those kids to long-term exposure to secondhand smoke in the home.

The problem is that once you regulate the smoking behavior of parents in the presence of their children, you have asserted jurisdiction over the issue. If you fail to ban smoking in the presence of children in the home, you now share responsibility for subjecting children to this exposure. Why? Because you could have acted to prevent such exposure, but you failed to do so.

Thursday, April 07, 2011

Yesterday, I called for the removal of Chantix from the market, arguing that the black box warning was not adequate to protect the public from the severe adverse side effects that have been observed with the drug. Today, I explain why it is that the black box warning is not sufficient to protect consumers.

The black box warning for Chantix notes the following:

"All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience. ... Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior."

The black box warning, then, advises physicians to observe patients being put on Chantix for "suicide-related events," including "suicide."

This simple question comes to mind: What use is it to observe patients for suicide? In what way does that protect the consumer? If a side effect of the medication is committing suicide within days of initiating therapy, how is monitoring the patient for suicide going to help?

The FDA itself has reported a typical case of Chantix-associated suicidal ideation as follows: "A 30 year-old female reported that she was taking varenicline 0.5 mg/day to help her quit smoking. She indicated that she had taken the pill for 5 days as directed. In her report, she stated, 'I became very depressed for no apparent reason and started having suicidal thoughts. I worried that I was going to hurt myself or someone else. I was also in a state of panic and unable to eat. I thought that I might go crazy and felt completely out of sorts. I quit taking the pill. About 36 hours later, I felt like myself again.'"

Fortunately, this woman stopped taking the medication. However, the story could easily have been different. Instead of stopping the medication, she could have instead attempted or committed suicide in response to her suicidal ideation. Monitoring patients like this for suicide attempts makes no sense. The purpose of monitoring is to prevent these adverse consequences -especially death - from occurring.

There are three situations in which a black box warning can be effective in protecting consumers. I will describe each of these situations and show why Chantix does not meet any of these criteria:

1. Early Detection of Side Effects Can Prevent Serious Adverse Consequences

One situation in which a black box warning may be appropriate is when monitoring of early side effects can prevent serious consequences. For example, if a side effect of a medication is liver damage, then monitoring a patient's liver enzymes for evidence of early liver injury can prevent serious disease by alerting the physician to this side effect so that the medication can be discontinued before it causes actual liver damage.

Chantix does not meet this criterion because its most worrisome side effect - sudden suicide - often occurs without warning, often in a matter of days following initiation of therapy. Relying on patients who become depressed to call their physician to report the symptoms is ineffective because one of the symptoms of depression is the inability to do just that. That the most worrisome side effect is not just depression but frank suicidality makes the black box warning ineffective in this regard.

2. Restricted Use of the Drug May Prevent Side Effects

A second situation in which a black box warning may be appropriate is when the severe side effects of the drug tend to occur only in certain patients. In this situation, warning physicians not to prescribe the drug to those patients can prevent the serious side effects. For example, if a drug causes blood clots only in people who are obese, then warning physicians not to prescribe the drug to patients who are obese will be effective in preventing this side effect.

This is not the situation with Chantix because its potentially lethal side effects have been observed to occur among all patients, not only those with existing psychiatric disease. In fact, FDA's review of Chantix side effects revealed that of cases of Chantix-related suicidal behavior in which psychiatric history was known, 44% of victims had no prior history of psychiatric disease.

3. The Benefits of the Drug Far Outweigh the Costs and Despite the Severe Side Effects, Physicians Should Use the Drug if Benefits Outweigh Risks for a Specific Patient

The third situation in which a black box warning may be appropriate is if the benefits of the drug far outweigh the costs on a societal level and the warning will ensure that physicians weigh the costs and benefits of the drug for the specific patient. For example, a drug that is used to treat cancer might have a severe adverse side effect but its benefits might still outweigh this cost if there are no other treatments available and so this is the only choice that patients have. This criterion will generally not be met if there are lots of other drugs on the market that are equally effective.

In my view, this criterion is not met for Chantix because this drug is not uniquely effective. There are many other treatments on the market (including a variety of nicotine replacement medications) that are equally effective. Moreover, the overall success rate with Chantix is still exceedingly low, and in the overwhelming majority of cases, the use of Chantix will not succeed in getting the patient to quit.

Under these circumstances, I simply do not see how the benefits of keeping Chantix on the market outweigh the many deaths that it has caused. It is not like this is some sort of wonder drug that is very effective in helping people quit smoking, nor is it like this drug is so much more effective than other smoking cessation drugs on the market.

Since none of these three criteria is met, I do not believe that the black box warning is appropriate and I reiterate my call for the removal of Chantix from the market.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.